Compositions and methods for treating nerve injury

a nerve injury and composition technology, applied in the field of compositions and methods for treating nerve injury, can solve the problems of loss of feeling or motor control of a portion of the body or pain or tingling in the region, loss of the ability to sweat or control blood flow in the region of the body, and inability to ensure full functional recovery. reliable treatment methods, to achieve the effect of effectively treating or preventing nerve injury

Pending Publication Date: 2020-11-12
MICROVASCULAR TISSUES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The disclosure provides methods for treating nerve injury, including peripheral neuropathy, using microvascular tissue preparations for topical and injectable administration. The compositions described herein can effectively treat or prevent nerve damage and can also help heal wounds and reduce the likelihood of recurrent diabetic foot ulcers. This technology has been developed through a patent text by the inventors of this patent.

Problems solved by technology

Although much knowledge exists on the mechanisms of injury and regeneration, no reliable treatments that ensure full functional recovery are known.
The result is a loss of feeling or motor control of a portion of the body or sensations of pain or tingling in the region.
If it involves autonomic nerves, then loss of the ability to sweat or to control blood flow in regions of the body may occur.
The loss of sensation often leads to chronic wounds, which are very difficult to heal.
Another known cause of nerve damage is excessive use of alcohol.
There is no successful cure for other forms of neuropathy though it is a focus of intense research.
The progression of diabetic neuropathy can be slowed by careful control of blood sugar levels, but no one has found a way to reverse the damage.
The pain or tingling in many instances of neuropathy can be very hard to live with, and therefore, many treatments aim to relieve these symptoms.
In the case of diabetic foot ulcers (DFU), sensation is usually lacking so these treatments are of little value.
Patients often cannot feel the wounds forming in time to change the loading on the affected area.
Once the wound has formed, it is difficult to heal because of the poor blood supply to the tissue, in diabetic patients.
Poor blood supply starves the tissue of nutrients needed for healing and allows infections to develop and persist in the wound.
Both of these established treatments are expensive and still fail to heal many wounds.
These two centrifuged products have provided benefits so meager they are hard to measure.
None of the many purported existing treatments for DFU provide, however, any noticeable healing of the associated neuropathy.

Method used

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  • Compositions and methods for treating nerve injury
  • Compositions and methods for treating nerve injury
  • Compositions and methods for treating nerve injury

Examples

Experimental program
Comparison scheme
Effect test

example 1

ization of a Multipotent Cell Preparation

[0129]The aim of these experiments was to develop and test convenient new products for treating DFU based upon multipotent cells. We targeted a dose of at least 1000 CFU-F or 105 CD90+ cells per square cm. We used multipotent cells isolated from human adipose tissue after mincing the fat, digesting with collagenase and neutral protease, and lysing red blood cells with ammonium chloride.

[0130]A batch of multipotent cells was produced from human adipose tissue and vialed and then characterized for phenotype and some growth factors of interest at contract labs. Cell count and phenotype were measured by INCELL, Inc. (San Antonio, Tex.) while growth factors were measured by ELISA at AssayGate (Ijamsville, Md.). The phenotype results show 5.5×105 CD90+ cells / vial.

[0131]To remove red blood cells, the sample was subjected to ammonium chloride solution. The preparation was assayed by ELISA in a total volume of 1 ml and gave the results tabulated below...

example 2

elivery to a Wound in a Limb with Neuropathy

[0132]The preparation of multipotent cells as characterized in Example 1 was lyophilized and sterilized by gamma irradiation. The resulting cake is porous, brittle and easily crushed to powder. The powder was sprinkled (topically) on diabetic foot ulcers after debridement and cleaning per standard wound care practice. The wounds were then covered with an occlusive dressing (Adaptic Touch™, San Antonio, Tex.) held in place with Steri-strips (3M, St. Paul, Minn.). Two patients received the multipotent cell preparation while a control patient received the same care without the addition of the multipotent cells. Healing of the DFU was measured weekly before reapplication of the multipotent cells and dressings. The extent of the patients' peripheral neuropathy was measured using the Von Frey method, where a monofilament fiber that bends at a calibrated force is used to probe the limb, moving up the leg until the patient can feel the fiber.

[0133...

example 3

ous Injection in Limb with Neuropathy

[0137]An adult male with diabetic neuropathy had lost much of his feeling below his left ankle. He was treated during one visit with 4 subcutaneous injections of the same preparation that was used in Example 2. Each injection consisted of 275,000 CD90+ cells dissolved in 1 ml of normal saline. The patient later reported a 60% improvement in sensation in his left foot and the improvement extended from his ankle to the region of the injections. Thus, the preparation did have a beneficial impact on the neuropathy, but it was not as pronounced as when the agent was applied topically to a DFU in the previously described patients.

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Abstract

The disclosure relates to new compositions for the treatment of neuropathy. The compositions of the disclosure provide increased efficacy in the treatment of diabetic neuropathy when applied topically to diabetic ulcers.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]The present application claims benefit of priority from U.S. Provisional Patent Application No. 62 / 614,948, filed on Jan. 8, 2018.FIELD[0002]The disclosure relates to compositions and methods for treating nerve injury, including peripheral neuropathy. In particular, the disclosure provides topical and injectable microvascular tissue preparations for treatment of nerve injury.BACKGROUND[0003]Nerve injuries are common conditions with broad ranging groups of symptoms depending on the severity and nerves involved. Although much knowledge exists on the mechanisms of injury and regeneration, no reliable treatments that ensure full functional recovery are known.[0004]Among the most common types of nerve injury is so-called peripheral nerve injury, including peripheral neuropathy. Peripheral neuropathy is an all too common condition in which peripheral nerves are damaged or destroyed. The result is a loss of feeling or motor control of a portion ...

Claims

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Application Information

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IPC IPC(8): A61K35/28A61K35/33A61K35/12A61K38/18A61P25/02A61K35/44A61K35/35A61L27/36A61K9/00
CPCA61K38/18A61K35/33A61K9/0014A61L27/3625A61K38/1825A61K35/28A61L27/3687A61K35/35A61K35/12A61K35/44A61K38/185A61P25/02A61K38/1841A61L27/3691A61K35/51A61K2300/00A61P1/04
InventorPETERSON, DALE R.OHASHI, KEVIN L.PICKETT, LAEL J.GONG, GLENEL-KALAY, MOHAMMAD A.MATTERN, RALPH-HEIKO
OwnerMICROVASCULAR TISSUES